40 Key EU FMD Terms for Pharmacists

September 11, 2018

Under the EU Falsified Medicines Directive (FMD), EU pharmacists will be required to verify and decommission medicines before dispensing them to patients beginning February 9, 2019. EU FMD introduces a wealth of new systems and terminology, along with the legal mandates.

AMVS—Austrian Medicines Verification System; National System through which Austrian pharmacists will verify medications. As of 11 September, the AMVS is live.

Anti-tampering Device—A safety feature applied to a pack to show evidence that a product or its packaging has been tampered with. Reduces the ease of replacing authentic product with Falsified Medicine.

B

BeMVO—Belgian Medicines Verification Organization; manages the National System through which Belgian pharmacists will verify medications. As of 11 September, BeMVO is live.

Bulk Verification—The processing of multiple verification requests in one go. If their FMD system supports it, pharmacists will be able to scan/enter multiple serial numbers before requesting verification, rather than processing them one at a time.

D

Data Matrix—A two-dimensional (2D) matrix barcode with dark and light cells in a square or rectangular matrix. Pharmacists must scan the Data Matrix in order to verify and decommission a pack.

Decommission—The process of informing the European Hub that a pack is leaving the supply chain. Pharmacists must decommission a medicine before dispensing it to a patient. To do so, the pack’s unique identifier must first be verified against the National System, to check it is safe to be dispensed. The unique identifier is then deactivated, so it cannot be re-used.

DMVO—Danish Medicines Verification Organization; manages the National System through which Danish pharmacists will verify medications. As of 11 September, DMVO is live.

E

EMVO—European Medicines Verification Organisation. A not-for-profit organisation that was set up to manage the European Hub.

European Hub—Also known as EU Hub. A system that acts as a central router for transferring data between pharmaceutical manufacturers and parallel distributors who place products into the supply chain and the national systems which serve as repositories for verification by pharmacy dispensers, wholesale distributors, etc.

e-VIS—e-Verifikationi Sverige, Swedish Medicines Verification Organization; manages the National System through which Swedish pharmacists will verify medications. As of 11 September, e-VIS is live.

F

FiMVO—Finnish Medicines Verification Organization; manages the National System through which Finnish pharmacists will verify medications. As of 11 September, FiMVO is live.

France MVO—French Medicines Verification Organization; manages the National System through which French pharmacists will verify medications. As of 11 September, France NMVO is live.

H

HOPAL—Croatian Medicines Verification Organization; manages the National System through which Croatian pharmacists will verify medications. As of 11 September, HOPAL is live.

HRI—Human Readable Interpretation. A GS1 term for the characters printed below, beside or above a barcode. HRI serves as a backup in situations where barcoded data needs to be manually processed.

I

ICEMVO—Icelandic Medicines Verification Organization; manages the National System through which Icelandic pharmacists will verify medications. As of 11 September, ICEMVO is live.

IMVO—Irish Medicines Verification Organization; manages the National System through which Irish pharmacists will verify medications. As of 11 September, IMVO is live.

K

KOWAL—Krajowa Organizacja Weryfikacji Autentyczności Leków, Polish Medicines Verification Organization; manages the National System through which Polish pharmacists will verify medications. As of 11 September, KOWAL is live.

L

LMVO—Luxembourg Medicines Verification Organization; manages the National System through which Luxembourgish pharmacists will verify medications. As of 11 September, LMVO is live.

LZVO—Latvian Medicines Verification Organization; manages the National System through which Latvian pharmacists will verify medications. As of 11 September, LZVO is live.

M

MAMVO—Malta Medicine Verification Organization; manages the National System through which Maltese pharmacists will verify medications. As of 11 September, MAMVO is not yet live.

MVO Portugal—Portuguese Medicines Verification Organization; manages the National System through which Portuguese pharmacists will verify medications. As of 11 September, MVO Portugal is live.

N

National System—The verification platform for one (or more than one) country, which is used at point of dispense by pharmacy dispensers or by other members of the supply chain to verify the product identifier encoded on medicinal packs. Each National System exchanges data with the European Hub.

NMVO—National Medicines Verification Organisation. A not-for-profit organization that is responsible for managing the NMVS in an EU Member State; e.g. Belgium’s NMVO is BeMVO.

NMVS—National Medicines Verification System. Managed by the relevant NMVO. Also referred to as National System.

NOOL—Czech Medicines Verification Organization; manages the National System through which Czech pharmacists will verify medications. As of 11 September, NOOL is live.

O

OSMR—Romanian Medicines Verification Organization; manages the National System through which Romanian pharmacists will verify medications. As of 11 September, OSMR is live.

P

Product status—Under EU FMD, a pack's product status refers to how it has been labeled in the National System. Pharmacists must check the pack's product status before dispensing it. Only pack's whose status is active can be dispensed. Other statuses include dispensed, expired, recalled, and stolen.

R

Recommission—The process of reactivating a pack’s unique identifier against the National System after it has been decommissioned. This can only be done within 10 days of decommissioning, and must be performed by the same organization, at the same location.

REKS—Estonian Medicines Verification Organization; manages the National System through which Estonian pharmacists will verify medications. As of 11 September, REKS is live.

S

Safety Features—Under EU FMD, safety features are the combination of the ATD and unique identifier.

SecurMed—UK Medicines Verification Organization; manages the National System through which UK pharmacists will verify medications. As of 11 September, SecurMed is expected to be live imminently.

securPharm—German Medicines Verification Organization; manages the National System through which German pharmacists will verify medications. As of 11 September, securPharm is live.

SEVeM—Sistema Español de Verificación de Medicamentos, Spanish Medicines Verification System, through which Spanish pharmacists will verify medications. As of 11 September, SEVeM is live.

SMVO—Swiss Medicines Verification Organization; manages the National System through which Swiss pharmacists will verify medications. As of 11 September, SMVO is not yet live.

SOOL—Slovak Medicines Verification Organization; manages the National System through which Slovakian pharmacists will verify medications. As of 11 September, SOOL is live.

Stichting NMVO—Dutch Medicines Verification Organization; manages the National System through which Dutch pharmacists will verify medications. As of 11 September, Stichting NMVO is live.

Supranational NMVS—a National System that covers medicine verification for more than one country, such as for Switzerland and Liechtenstein.

U

Unique Identifier—Under EU FMD, the unique identifier refers to the collection of data elements that must appear on every pack: product code, serial number, national number (if required by the target market), batch number, and expiry date.

V

Verification—The process of checking a pack’s product data against the National System. Upon verification request, the National System will inform you of the pack’s current status, according to its unique identifier: active, expired, recalled, stolen, or decommissioned.

Z

ZAPAZ—Slovenian Medicines Verification Organization; manages the National System through which Slovenian pharmacists will verify medications. As of 11 September, ZAPAZ is live.